The role of your biostatistician for success in medical device clinical trials

medical device clinical trials

The importance of biostatistics in medical device clinical trials

In order to understand the importance of biostatistics in medical device clinical trials we talked to Dr. Lisa Deutsch.

Lisa Deutsch, Ph.D is a Managing Partner at BioStats Statistical Consulting Ltd. Lisa is one of the rare breed of biostatisticians that are specialized practitioners in biostatistics as consultants to sponsors in medical device clinical trials.

Starting off as a maths student with hopes of becoming an actuary one day, Lisa soon found out that statistics are much more interesting for her and moved into that field and as she says herself “stayed there forever”.

Her natural tendency towards all things scientific, especially in the medical field combined with the efforts of Master’s and Ph.D. supervisors (Linda Har-Nevo and Laurence Freedman respectively) effectively synthesized Lisa’s 2 passions- mathematics and biology, making her an exceptional professional in the unique space of statistical analysis planning and execution for clinical trials.

Lisa tells that while she was still at University, people started looking for consultancy and sought her advice, then got her first big time consultancy job from which eventually pulled into clinical trials and  consulting to Israeli medical device manufacturers in the are of applications for FDA approval.

The uniqueness of a medical device requires a rigorous scientific approach

Each medical device is unique in almost respects from perspective of intended use, engineering, data model, efficacy and safety.   Lisa started working in medical statistics and had to learn how to answer questions on her own and she developed her own skill-set.  That involved meticulous attention to details and thorough checking and developing a rigorous scientific approach to evaluating efficacy and safety of medical devices in clinical trials.

Trends in society drive innovative medical devices

According to Lisa, we are seeing rapid innovations and achievements in medical devices particularly in automated diagnosis and robotic procedures which are very hot fields.

People are trying to automate medicine using software as medical devices to enable quick and accurate diagnostics, to facilitate treatment, and to monitor the patients’ progress and improve clinical outcomes.

Other drivers of medical device innovations in Israel are connected with limited resources in terms of clinics and health care personnel and an aging population which create a booming market for medical device clinical trials in Israel.

As the population gets older, more people retire and the medical profession is no exception. Following the collapse of the Soviet Union, Israel experienced a huge influx of nurses and physicians. In about 20 years’ time, many of them will head towards retirement: this combined with aging population puts a great deal of pressure on Israeli healthcare.

Scientific testing in medical device clinical trials

As a result of an economy that does not have the economic resources of the US – Israeli medical device innovation is increasing turning towards automation – automation of patient adherence, automation of medical diagnosis and automation of patient monitoring.    All of this medical innovation needs to be tested scientifically in clinical trials.

The role of the biostatistician in medical device clinical trials

The role of the biostatistician in medtech clinical trials starts before the first patient enters the study with a SAP – a statistical analysis plan.  The SAP describes the planned analysis for a series of clinical trials and relates to the primary endpoints of the medical device trials, the safety endpoints and do that based on the medical device trial clinical protocol.   A SAP requires statistical expertise and abstract thinking skills.  During the medical device clinical trial, the biostatistician will be called upon to perform an interim analysis and at the end of the study a final statistical analysis to assess the efficacy and safety of the medical device.

Strong patient adherence in real life starts with strong people management


Patient adherence in real-life starts in clinical trials determining the safety, side effects and efficacy of the intervention, whether a drug or a medical device.

Like any other industry – success in clinical trials is all about the people.

The hugely successful movie – “Hidden figures” tells the story of the gifted black women mathematicians who played key roles in the NASA space program in the Mercury and Apollo space programs. It is a moving, inspiring and (sometimes hilarious) story of how NASA, a dominantly white male organization came to accept diversity during American desegregation.

By comparison, the Israeli life science industry lives in a different time and place and women are in leadership roles at all levels  of Israeli life science companies.

In this 4 part series of articles, we will tell the story of the gifted Israeli women who are the   “Hidden figures” of the Israel biomed/biotech industry.

Women comprise about 65 percent of Israel’s biotechnology workforce, and about 13 percent of top management positions in companies listed on the Tel Aviv Biomed index. In order to find out what attracts Israeli women into this globally male dominated field, I talked to a number of well-respected women, tried to learn about their story, get acquainted with their mindsets and solve the “mystery” of Israeli women invading this field.

Part 1 of the series tells the story of Hagit Nof – former Country Manager of IQVia in Israel and  currently the COO & BD of nRollmed an Israeli startup that helps clinical trial sponsors speed up their study using online patient recruitment and optimization.

(IQVia is the world’s largest provider of biopharmaceutical development and commercial outsourcing services ).

Hagit has a great story of a dream come true for a person who was not afraid to make a risky decision at the right time and was able to build a career in the biopharmaceutical industry literally from scratch.


What real-time data and Risk-based monitoring mean for your CRO

A widely neglected factor in cost-effective risk-based clinical trial monitoring is availability and accessibility of data.

RBM methods used by a central clinical trial  monitoring operation that receives stale data (any data from patients that is more than a day old is stale) are ineffective. Every day that goes by without having updated data from patients, devices and investigators reduces the relevance and efficacy of remote monitoring.

Real-time data is a sine-que-non for RBM.

Sponsors and Contract research organizations (CROs) should therefore approach real-time data and risk-based monitoring (RBM) as 2 closely related priorities for executing clinical trials. Use of modern data technologies for real-time data collection and remote risk-based monitoring will reduce non-value added rework, people and paper in clinical trials and help speed up time to statistical report.


The 3 tenets for designing a clinical data management system

This post reviews the importance of 1) proper study design, 2) good data modeling and 3) realistic estimation of project timetables. The article concludes with a discussion of eSource and attempts to dispel some of the myths including how DIY EDC study build save time (they don’t).


The trend of DIY: good for EDC vendors, less good for sponsors

The trend for small studies/IIS (investigator-initiated studies) is to use cloud EDC applications
that enable end-users to build eCRF and edit checks using a graphical user interface. This so-called DIY (do-it-yourself) approach is used by most cloud EDC vendors such as Medrio and Clincapture as a way of lowering their barriers to entry to the market.

However – what is good for vendors (lowered barriers to entry) is not necessarily good for sponsors (faster time to market of their innovative drug or medical device).


Medical device clinical trials – not for the faint of heart

Patients in medical device clinical trials are on their phones.  On their phones for WhatsApp and for monitoring chronic conditions and reporting outcomes at home, at work and in the middle of a call to their friends.

Medtech developers are looking to make their product development process as effective as  possible and are facing conflicting requirements when it comes to meeting regulatory requirements and reimbursement opportunities.


Millennials are the future of clinical trial data management

esource tp get smart to market

Millennials, born between 1980 and 2000 and the first native generation of the digital age, are the quickly approaching additions to the modern workforce. Regardless of whether private or public sector Millennials are soon to become the bulk of the global workforce.

At present, Millennials represent 34% of the current US workforce (up 9% from 25% in 2015), and by 2020 50% of workers will be of the Millennial generation. As the demographics of present job seekers continues to shift, companies need to adjust their culture, facilities and technology to cater to the new generation.

Regarding the clinical trial industry, Millennials are not only the next generation of data managers and monitors, but will soon make up the bulk of the study subjects as well.

Choosing the right tool and UX for millennial subjects becomes acute considering usability factors and patient compliance issues for people under 30.


Risk based monitoring. It’s about the people.

esource for people in clinical trials

It will come as no surprise to anyone who is actively involved in clinical trial operations that the heart of the matter in clinical trial monitoring is people.

I have written herehere and here about how people are the key assets and vulnerabilities in medical device clinical trials.

Understanding people and providing timely and high-quality communications rests is a key to data-driven decision making. There may be high value in the analysis of the data (for example – inconsistencies in dosing at sites) but if the data is not communicated in a timely and effective manner, risk based monitoring will not be effective or timely either!

MANA RBM risk based monitoring is a consultancy based in Denver CO, led by Penelope Manasco MD, that provides CRO and consulting services around risk-based monitoring. Dr. Manasco recently published an article  It Takes a Village to Achieve Risk-Based Monitoring that discusses the “people” components needed to successfully adopt Risk Based Monitoring. It also compares the roles of the Site Monitor and Central Monitor and discusses the role of risk assessment, training, and implementing Risk-Based monitoring solutions.

Good job!

There are sites who are outstanding, entering high quality data within 24 hours of the patient visit and then there are sites who take 2-3 weeks to enter data, enter future events and are not always careful regarding informed consent and participation in the trial.

This is a people issue not a technology issue.

Jenya Konikov-Rozenman is product lead at Jenya has a masters degree in biotechnology from the Hebrew University and is a doctoral candidate at Tel Aviv in medical science. She is GCP and CRA certified and leads with super-human devotion to customer delivery.

Important EDC features for medical device clinical trials

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Medidata Rave and its CTMS companion product iMedidata are a far more comprehensive solution than OpenClinica but when you choose EDC software for medical device clinical trials, you enter a realm of unique requirements involving connectivity, security, privacy, API integration and specific interfaces to hardware.

Electronic data capture software (EDC software) systems have demonstrated that their value is manifest for clinical trial efficiency and cost savings. Soon, medical device clinical trials will no longer be dependent upon paper-based systems at all. Paper is great for passing notes in class, but how often does that even happen anymore? Kids in school are more likely to use Snapchat or simply text each other.

As someone said recently – “millenials are off Facebook, adults still use email”.


Implementing an EDC to take advantage of risk-based monitoring

Clinical trial monitoring is 30-40% of your project costs.    At least half of that cost is manual work and SDV activities which can be eliminated with use of modern technologies like electronic source documents and remote risk-based monitoring.

In this post, we take a look at how you can automate routine data management activities and eliminate costly manual labor of your study monitors.  In order to eliminate costly people and paper processing, we need to  implement a strategy of “management by exception” or as the FDA calls it “remote risk-based monitoring“.

For the benefit of connected medical device developers who  are new to clinical trial operations and data management,  or new to electronic data capture (EDC) for clinical studies; this post starts with an introduction to FDA guidance on remote risk-based monitoring and goes on to provide some practical suggestions for using your EDC system within a remote risk-based monitoring plan for your connected medical device study.


Integrating mHealth in medical device clinical trials

patient compliance in medical clinical device trials


mHealth evolved largely an application for developing countries, due to the rapid growth of mobile phone penetration in low-income nations.

But mHealth is now a game-changer for clinical trials, enabling electronic patient reported outcomes and integration with medical devices using standard hardware and mobile operating systems.

There are 3 key use cases of mHealth in medical device clinical trials:

1. ePRO – patient reported outcomes using smartphone apps that integrate with EDC APIs

2. As a mediation layer for medical devices, enabling a medical device to obtain connectivity to the EDC by communicating with a mobile app over BLE (blue tooth low energy).

3. As a mobile medical device in its own right

Why Android is the biggest selling medical device in the world

After a short marketing review of why Android is already the biggest selling medical device in the world, I’ll review FDA requirements for clearing mobile medical devices which need to be taken into account before bringing mHealth (mobile medical apps) into your connected medical device clinical trial.

Connected medical device vendors moving into clinical trials need to consider the regulatory requirements in advance since they are in a near-real-life situation with patients during their trials and will probably be using a similar configuration in post-marketing.

The marketing stats

In 2016, publishers of mobile health apps brought to market 100,000 more apps, a 57% increase over 2015. This brought the total to 259,000 health apps globally available to consumers, according to new study mHealth App Developer Economics 2016 conducted by health research group Research 2 Guidance. By 2017  there were 325,000 mobile health apps available online and Android is now the leading mHealth platform

With its global popularity and a large developer community – Android is a natural choice as a tool for data management in your clinical trial or as middleware for your connected medical device.